Full face respiratory mask with integrated nasal interface

ABSTRACT

A patient interface that reliably and comfortably seals a user&#39;s face by providing an oral-nasal mask that includes an integrated nasal interface. The patient interface includes a seal member having an oral cushion portion configured to surround the user&#39;s mouth and a nasal interface portion that provides an interface with the user&#39;s nose. The seal member, including the oral cushion portion and the nasal interface portion, is a unitary member. Finally, the nasal interface portion remains below the bridge of the nose.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) fromprovisional U.S. patent application No. 60/748,311, filed Dec. 7, 2005,the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates, in general, to a full face mask thatprovides a sealed interface with the nose and mouth of a user, and, inparticular, to a full face mask having an oral cushion portion thatseals generally around the mouth and a nasal interface portion thatseals generally at or around the nares and remains below the bridge ofthe nose.

2. Description of the Related Art

A variety of respiratory masks are known that have flexible seals, covera portion of a user's face, and are designed to create a seal againstthe user's face. Because of the sealing effect that is created, gasescan be provided at a positive pressure within the mask for consumptionby the user. The uses for such masks range from high altitude breathing,i.e., aviation applications, to mining and fire fighting applications,to various medical diagnostic and therapeutic applications. For example,such masks are used in the delivery of continuous positive airwaypressure (CPAP) or variable airway pressure, which varies with theuser's respiratory cycle or which varies with the condition of the user,to treat a medical disorder, such as sleep apnea syndrome, obstructivesleep apnea (OSA), congestive heart failure, and cheynes-stokesrespiration.

A requisite of such respiratory masks is that they provide an effectiveseal against the user's face to prevent leakage of the gas beingsupplied. Commonly, in prior mask configurations, a good mask-to-faceseal has been attained in many instances only with considerablediscomfort to the user. This problem is most crucial because such masksare typically worn for an extended period of time. One concern in such asituation is that a user may avoid wearing an uncomfortable mask,defeating the purpose of the prescribed pressure support therapy.

A wide variety of patient interfaces are known, including nasal masksthat cover only the nose, nasal canulas or prongs that fit into thenares of the user, total face masks that cover a majority of the user'sface, oral-nasal or full face masks that cover the nose and mouth area,among other variations.

Traditional oral-nasal masks cover the entire nose and mouth area of theuser. Due to their size and bulk, they may be less comfortable and moreintrusive than other masks. Some users may resist the wearing oforal-nasal masks due to physiological reasons, such as claustrophobia orclithrophobia (fear of being enclosed). Oral-nasal mask are typicallyheavy and bulky, may interfere with a user's facial comfort, and may notfacilitate the wearing of eyeglasses. Some oral-nasal masks may irritatea user's nose bridge, which typically is an area of thin skin, whereeven slight pressure can cause a blood flow constriction, and, hence,skin breakdown and/or discomfort.

It can be difficult to achieve a good seal in typical oral-nasal masksdue to the large and varied area being covered. This area includes thearea around the mouth, the front of the face from the ends of the mouthto the nose, and the nose itself, including the bridge. The variationsin contour and size from nose to mouth are much greater than those amongthe nose or among the mouth alone.

Another disadvantage of conventional masks is the forehead support.Typically, forehead supports stabilize the mask system as well asproviding pressure point relief. The forehead support, however, is oftenthe source of pressure point and skin break down.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide apatient interface that overcomes the shortcomings of conventionaloral-nasal masks. This object is achieved according to one embodiment ofthe present invention by providing a patient interface that includes afaceplate and a seal member coupled to the faceplate. The seal membercontacts the user's face to provide a sealed interface with the user.The seal member includes an oral cushion portion and a nasal interfaceportion. The oral cushion portion provides a sealed interface with theuser over a sealing area that at least partially surrounds the user'smouth. The nasal interface portion is integral with the oral cushionportion and contacts at least a portion of the user's nose below thebridge of the nose. The nasal interface portion provides a sealedinterface with a surface of such a user proximate to the nares of such auser. The patient interface having this configuration provides acontacting area on the user's face that is less than conventionaloral-nasal masks and also reduces the complexity of sealing, becauseboth the sealing surface and the variation among the surfaces isreduced.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of a patientinterface according to the principles of the present invention shownschematically coupled to a pressure generating system;

FIG. 2 is a side view of the patient interface of FIG. 1;

FIG. 3 is a rear view of the patient interface of FIG. 1;

FIG. 4 is an exploded view of the patient interface of FIG. 1;

FIG. 5 is a cross-sectional view of the patient interface of FIG. 1taken along line 5-5 of FIG. 3;

FIG. 6 is a side view of a second embodiment of a patient interfaceaccording to the principles of the present invention;

FIG. 7 is an exploded view of the patient interface of FIG. 6;

FIG. 8 is a front perspective view of a third embodiment of a patientinterface according to the principles of the present invention;

FIG. 9 is a side view of the patient interface of FIG. 8;

FIG. 10 is a rear perspective view of the patient interface of FIG. 8;

FIG. 11 is an exploded view of the patient interface of FIG. 8;

FIG. 12 is a rear perspective view of the seal member of the patientinterface of FIG. 8;

FIGS. 13 and 14 are front and rear perspective views of a headgear clipused in the patient interface of FIG. 8;

FIG. 15 is front perspective view of a fourth embodiment of a patientinterface according to the principles of the present invention;

FIG. 16 is a side view of the patient interface of FIG. 15;

FIG. 17 is an exploded view of the patient interface of FIG. 15;

FIG. 18 is front perspective view of fifth embodiment of a patientinterface according to the principles of the present invention;

FIG. 19 is a rear perspective view of the patient interface of FIG. 18;

FIG. 20 is a side view of the patient interface of FIG. 18;

FIG. 21 is an exploded view of the patient interface of FIG. 18;

FIG. 22 is a cross-sectional view of the patient interface of FIG. 18taken along line 22-22 of FIG. 19;

FIG. 23 is front perspective view of a sixth embodiment of a patientinterface according to the principles of the present invention;

FIG. 24 is a side view of the patient interface of FIG. 23;

FIG. 25 is a first rear perspective view of a seventh embodiment for aseal member according to the principles of the present invention;

FIG. 26 is a second rear perspective view of the seal member of FIG. 25;

FIGS. 27-30 are perspective views of eighth-eleventh embodiments for thepatient interfaces according to the principles of the present inventionshown being worn by a user as part of various patient interfaceassemblies;

FIG. 31 is a side view of a human nose illustrating the variousanatomical features and the location on the nose for the nasal interfaceportion of the seal member according to the principles of the presentinvention;

FIGS. 32-34 are front perspective, rear perspective, and cross-sectionalviews, respectively, of a twelfth embodiment of the patient interfaceaccording to the principles of the present invention;

FIGS. 35 and 36 are front and rear perspective views of a thirteenthembodiment of a patient interface according to the principles of thepresent invention;

FIGS. 37 and 38 are front and rear perspective views of a fourteenthembodiment of a patient interface according to the principles of thepresent invention;

FIGS. 39-41 are front perspective, rear perspective, and exploded views,respectively, of a fifteenth embodiment of a patient interface accordingto the principles of the present invention;

FIG. 42 is a perspective views of a sixteenth embodiment of a sealmember according the principles of the present invention;

FIG. 43 is a perspective views of an seventeenth embodiment of a sealmember according the principles of the present invention;

FIG. 44 is a perspective view of an eighteenth embodiment of a patientinterface according to the principles of the present invention shownbeing worn by a user;

FIG. 45 is a side view of the patient interface of FIG. 44;

FIG. 46 is a side view of a nineteenth embodiment of a patient interfaceaccording to the principles of the present invention;

FIG. 47 is a side view of a twentieth embodiment of a patient interfaceaccording to the principles of the present invention;

FIG. 48 is a perspective view of a twenty-first embodiment of a patientinterface according to the principles of the present invention;

FIG. 49 is a rear view of the patient interface of FIG. 48;

FIG. 50 is an exploded view of the patient interface of FIG. 48;

FIG. 51 is a perspective view of a twenty-second embodiment of a patientinterface according to the principles of the present invention;

FIG. 52 is a rear view of the patient interface of FIG. 51; and

FIG. 53 is an exploded view of the patient interface of FIG. 51.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIGS. 1-5 represent a first exemplary embodiment of a patient interface110 according to the principles of the present invention. Patientinterface 110 includes a faceplate 112 and a seal member 114 attached tofaceplate 112 for contacting the user's face. Faceplate 112 has a userside to which a seal member 114 is attached, and an exterior side,opposite the user side, and adapted for receiving a supply ofpressurized breathing gas. A conduit 116 is connected to the exteriorside of faceplate 112 via a patient interface coupling 118. Conduit 116,which is typically a flexible tube and is known in the art as a “patientcircuit”, delivers gas produced by a pressure generating device 120 topatient interface 110. An opening 117 is provided in the faceplate tocommunicate a flow of gas between a chamber 119 defined in the patientinterface and conduit 116.

The present invention contemplates that pressure generating device 120is any conventional ventilation or pressure support system. Examples ofsuch pressure support systems include, but are not limited to: aventilator, continuous positive airway pressure (CPAP) device, or avariable pressure device, e.g. an auto-titrating device in which thepressure varies with the condition of the user, such as whether the useris snoring, experiencing an apnea, hyponea, or upper airway resistance.Still other examples of pressure support systems include a proportionalassist ventilation (PAV®) device, proportional positive airway pressure(PPAP®) device, C-Flex™ device, Bi-Flex™ device, or a BiPAP® devicemanufactured and distributed by Respironics, Inc. of Pittsburgh, Pa., inwhich the pressure provided to the patient varies with the patient'srespiratory cycle so that a higher pressure is delivered duringinspiration than during expiration, or other pressure support device.

Patient interface 110 of the present invention is an oral-nasal maskconstructed to interface with both the user's nose and mouth. Masks thatinterface with the nose and mouth simultaneously are also known as fullface masks. Seal member 114, which is also referred to as a cushion, isconfigured to surround the user's mouth while also providing anintegrated, one-piece unitary interface with the user's nose. In theembodiment shown in FIGS. 1-5, seal member 114 is a unitary member thatincludes an oral cushion portion 122 and a nasal interface portion 124.Oral cushion portion 122 provides a sealed interface with the over asealing area that at least partially surrounds the user's mouth. Nasalinterface portion 124 is integral with oral cushion portion 122 andcontacts at least a portion of a nose of the user below the bridge toprovide a sealed interface with the surface of the user proximate to thenares. That is the present invention contemplates that the nasalinterface portion contacts the nose, including extending over the tip ofthe nose and extending up the nose, but not so high so to cover thebridge of the nose.

To better understand where the present invention contemplates that thenasal interface portion of the seal member contacts the user, FIG. 31 isprovided, which illustrates the anatomical features of a human nose 131.As shown in this figure, the human nose includes a nasal bone 133 thatextends from between the eyes (not shown), toward the mouth, andterminates somewhere above or near the middle of the nose. Thetermination point of the nasal bone is indicated by line 135. Above line135, as indicated by arrow 137, is the nasal bone, and below line 135,as indicated by arrow 139, is the cartilage of septum. In referring tothe “bridge of the nose”, the present invention is referring portion ofthe nose where the nasal bone lies with respect to the midline of thenose, i.e., the portion of the nose above line 135, as indicated byarrow 139, along the ridge of the nose.

Thus, in describing the nasal interface portion of the seal member ofthe present invention as contacting the user below the bridge of thenose, the present invention is referring to a seal having a usercontacting area that is at or below line 135 (the end of the nasalbone), as indicated by arrow 139, with respect to the mid-line of thenose. The present invention contemplates that the contacting area of thenasal interface portion can extend along the flanks of the nose, so longas the sealing area remains below line 135, even if the seal memberoverlies the nasal bone on the side of the nose, such as at area 141.However, in an exemplary embodiment of the present invention, the nasalinterface portion of the seal member this invention rests on and sealsagainst the soft tissue around the lower portion of the lateralcartilage of the nose on the nasal septum, as indicated by area 143.

Seal member 114 is preferably formed from a flexible material such assilicone. Seal member 114 provides a seal that minimizes contact withthe user's face by integrating a tip-of-the-nose or nostril seal with amouth cushion, which, in an exemplary embodiment, is oval-shaped andonly circles the mouth and remain below the bridge of the nose. Thus,the seal member of the present invention limits contour variation, suchas the variation of the nose to mouth transition, thereby making iteasier to provide an effective seal with the surface of the user, whichultimately maximizes patient comfort and compliance with the prescribedpressure support therapy.

The present invention contemplates that the faceplate and the sealmember, including the oral cushion portion and the nasal interfaceportion, can have a variety of configurations. Many of these possiblealternative configurations are illustrated in the attached figures anddescribed below. A first embodiment for the faceplate and seal memberaccording to the principles of the present invention shown in FIGS. 1-5will now be described.

As can perhaps best be seen in FIGS. 4-5, oral cushion portion 122 is agas-filled cushion having a U-shaped cross section. An exemplaryembodiment of a gas-filled cushion suitable for use in the presentinvention is disclosed in co-pending provisional U.S. patent applicationSer. No. 11/599,133, (“the '133 application”) the contents of which areincorporated herein by reference.

Oral cushion portion includes a curved portion 126, an inner side wall128, an outer side wall 130, and an interior 132. Oral cushion portion122 is preferably formed from liquid injection molded silicone, butcould be formed from other suitable materials. Oral cushion portion 122has a varied wall thickness as shown in FIG. 5. However, the presentinvention also contemplates the oral cushion portion 122 can have auniform wall thickness. The inner and outer side walls 128, 130 of oralcushion portion 122 have interiorly disposed, U-shaped grooves 134 attheir ends opposite curved portion 126.

To mount seal member 114 to faceplate 112, oral cushion portion 122 iscoupled to a two-piece base or mounting ring 136, 138. Two-piece base ormounting ring

Upper mounting portion 136 and lower mounting portion 138 are assembledwith oral cushion portion 122. In the illustrated embodiment, lowermounting portion 138 cooperates with oral cushion portion 122 to sealthe open end of interior 132 forming a sealed gas-filled chambercorresponding to interior 132. In this embodiment, the oral cushionportion is configured such that the oral cushion portion extends aroundthe mouth but is not located at the portion of the oral cushion portionunderlying the nose. Upper mounting portion 136 cooperates with theportion of oral cushion portion 122 that cooperates with or forms nasalinterface portion 124 to the nasal interface portion of the seal memberto faceplate 112. Snapping members 140 are inserted into correspondingmounting members 146 on faceplate 112. It is to be understood that thepresent invention contemplates using other suitable assemblies to attachseal member 114 to faceplate 112 in this or any of the otherembodiments.

In the illustrated embodiment, gas-filled chamber 132 is inflated ordeflated through a valve (not illustrated in FIGS. 1-5, see valve 450 inFIGS. 15-17) incorporated in faceplate 112. The valve cooperates withgas-filled chamber 132 through a hole 150 in faceplate 112 and acorresponding hole 152 in lower mounting portion 138. The valve may besyringe or a manually operated gas blowing device. Of course, thepresent invention contemplates eliminating the valve in favor of a fixedvolume of gas in interior 132 of seal member 114.

If chamber 132 is filled from the ambient atmosphere, the gas in thechamber is typically air. However, the present invention contemplatesthat the gas in chamber 132 can be any suitable gas or gas mixture. Inaddition, the present invention contemplates that chamber 132 can befilled with any suitable material in addition to or in place of gas,such as fluid, gel, foam, or any combination thereof. Examples ofsuitable gel materials are disclosed in U.S. Pat. Nos. 5,647,357 and5,884,624 the contents of which are incorporated hereby by reference.The present invention also contemplates that the material in oralcushion portion 122 can be a material that can be shaped and maintainthe new shape. Examples of suitable gel materials that have shaperetention properties are disclosed in U.S. Pat. Nos. 6,397,847 and6,895,965 the contents of which are incorporated hereby by reference.

The present invention also contemplates providing an optional pressurerelease valve to regulate the level of inflation of the seal member orportions thereof through the control of internal pressure to enhancecomfort. The valve provides an upper limit to the pressure inside theair-filled chamber. When the mask is strapped on a user's face, air isdisplaced such that internal pressure increases inside the gas-filledchamber. Once the internal pressure exceeds the pre-set value, therelease valve opens and lets excessive air out, thus, reducing strappingand pressure points.

Oral cushion portion 122 surrounds the mouth of the user forming asealing interface therewith. Nasal interface portion 124 extends fromthe top of oral cushion portion 122 and has generally V-shaped contoursides 125 that wrap around the sides of the user's nose (see FIG. 3).Nasal interface portion 124 has a relatively low profile so that it doesnot come in contact with the bridge of the user's nose. Nasal interfaceportion 124 is bounded at its upper extremity by the lower end of theuser's nose including the tip and lateral flanks thereof. In theillustrated exemplary embodiment, nasal interface portion 124 is formedfrom a flexible peripheral wall 154, which has a base 156 integral withcushion flap portion 122 and an outer contoured portion 158. Extendingfrom outer contoured portion 158 is an in-turned surface 160 forcontacting the user's nose. Nasal interface portion 124 forms aninterface that is open to the pressurized interior (chamber 119) of thepatient interface via notched opening 161. Because the highest point ofthe patient interface remains below the bridge of the nose when in use,the user is able to wear glasses and easily access his or he eyes whilethe patient interface is being worn.

Faceplate 112 has a generally oval shape that is contoured to the faceof a user such that ends 162 of the oval wrap around the sides of theuser's face on either side of the user's mouth. Faceplate 112 is amember formed from a rigid or semi-rigid plastic, such as Polycarbonate.However, the present invention also contemplates that the faceplate canbe formed from other materials, such as cloth or other fabric, or anelastomer, or any combination thereof. Thus, the faceplate can be aflexible member.

Faceplate 112 has a generally circular opening 117 to which coupling 118is rotatably attached. Coupling 118 has a conduit connection portion 166and an exhalation/entrainment valve portion 168. In conventional masks,the circular opening for attachment of the conduit coupling typicallylies in a plane that is perpendicular to the seal member. In the presentinvention, opening 117 lies in a plane, as generally indicated by line170 in FIG. 2, that is at an angle with respect to the plane of sealmember 114, as generally indicated by line 172. These two planes areangled with respect to on another because when patient interface 110 isdonned by the user, the upper portion of the patient interface (namelythe nasal interface portion) will be moved toward the user further thanthe lower portion. The angle between planes 170 and 172 ensures thatconduit connection portion 166 is disposed at angle that more in linewith the typical position of conduit 116 in a conventional oral-nasalmask.

Patient interface 110 is held in place on a user's face by a headgear,examples of which are shown in FIGS. 27-30 and discussed below. Theheadgear includes straps that attach to the patient interface. Thepresent invention contemplates that any technique for attaching theheadgear straps to the patient interface can be used in the patientinterface of the present invention. One embodiment is discussed belowand is also disclosed in the '133 application. It is to be understoodthat any other headgear attachment technique is contemplated by thepresent invention. For example, U.S. Pat. Nos. 7,066,179 (“the '179patent”) and 7,069,932 (“the '932 patent”), and in U.S. patentapplication Ser. No. 11/449,111 (publication no. 2006 0225740) (“the'111 application”), the contents of each of which are incorporatedherein by reference, discloses a ball-and-socket and other headgearattachment technique suitable for use with the patient interface of thepresent invention.

To attach the headgear straps to faceplate 112, attachment rails 174provided on each end of the faceplate. Each attachment rail includesmultiple position slots 176 for receiving a stem of a headgearattachment clip (see headgear clip 914 in FIG. 27) attached to aheadgear straps. Each slot includes a plurality of notches 178 anddetents (areas between adjacent notches) so that the stem or otherportion of the headgear attachment clip can rest at a particularlocation along the length of each slop. Openings 180 are provided at theends of rails 174 to allow the stem to be inserted into slots 176.

The headgear may be releasably attached to patient interface 110 ateither two points or four points corresponding to two or four slots onthe mask. This provides a multiple position anchoring option for theuser to improve and customize attachment stability, thus, eliminatingthe need for a forehead support and allows for stability even when usingonly a two point attachment arrangement. Also, because the mask does notextend as high on the face as a conventional oral-nasal mask, noattachment point is needed near the eyes or upper nose. It is to beunderstood, however, that the present invention contemplates using anyconventional connection assembly to attach a headgear to faceplate 112in this or any of the other embodiments.

The present invention contemplates the headgear that can be used withrespiratory mask 110 can be any suitable headgear, i.e., anyconventional headgear used in the patient interface field. For example,a typical headgear assembly comprises a headpiece that overlies aportion of the user's crania and with headgear straps extendingtherefrom to adjustably connect the headgear to the mask.

Alternative exemplary embodiments of the patient interface, i.e.,respiratory mask, of the present invention are illustrated in FIGS.6-22. In these embodiments, many features are similar to thoseillustrated in FIGS. 1-5. Thus, the description of this embodiment willfocus primarily on the features unique to each embodiment. It is to beunderstood, however, that the present invention contemplates otherconfigurations for the present invention and mixing and matching of thefeatures of the elements illustrated in all of these embodiments.

A second exemplary embodiment is shown in FIGS. 6 and 7. In thisembodiment, patient interface 210 includes a faceplate 212 and a sealmember 214 having an oral cushion portion 222 and nasal interfaceportion 224. Faceplate 212, however, is not contoured as in theembodiment of FIGS. 1-5, but has a generally flat profile. A two-piecemounting ring defined by portions 236 and 238 are used to couple theseal member to the faceplate. Thus, portions 236 and 236 correspond tomounting rings 136 and 138 from the embodiment of FIGS. 1-6. Snappingmembers 240 in the form of dual snap members 240 on cantilever arms 242are used to couple the portions of the mounting ring to the faceplate.Receptacles 250 are provided on faceplate 212 to receive these snapmembers.

It should be noted that while a two-piece mounting ring has been shownand described for mounting the seal member to the faceplate, ringsdefined by a single piece, or by more than two pieces, are contemplatedby the present invention. In addition, the mounting ring can be madefrom any suitable material, such as plastic. It can be rigid,semi-rigid, or flexible. It can also be eliminated entirely if the sealmember is mounted directly to the faceplate. As also noted above, othertechnique for fastening the mounting ring to the faceplate arecontemplated by the present invention. For example, the presentinvention contemplates that the mounting ring surrounds the perimeter ofthe seal member and attached to the faceplate using tabs such that theseal member is captured between the mounting ring and the faceplate.

A third exemplary embodiment is shown in FIGS. 8-14. In this embodiment,patient interface 310 has a faceplate 312 and a seal member 314 havingan oral cushion portion 322 and a nasal interface portion 324. However,the nasal interface portion in this embodiment is in the form of a nasalpillows or prongs 330 that are insertable into the nares of a user andstructured to sealingly engage with nasal passages of a user's nose.Rather than wrapping or sealing against the exterior surface of the noseas in previous embodiments, nasal pillows 330 seal around each naris.Nasal interface portion 324 also includes a gusset or base portion 332that supports nasal pillows 330. Each nasal pillow has a hole 334 in itsdistal end. Holes 374 communicate the user's airway with the pressurizedinterior 119 of patient interface 310. Like the embodiment of FIGS. 1-5,seal member 314 attaches to shell by a two-piece mounting ring 336, 338(see FIG. 11).

A headgear as shown, for example, in FIGS. 27-30, may be releasablyattached to patient interface 310 by means of hook clips 340 thatselectively attach to each side of faceplate 312. As shown in FIGS. 13and 14, hook clips 340 include a pair of engaging arms 342 and aretaining arm 344. A number of openings 350 are provided on each side offaceplate 312 for receiving engaging arms 342 (see FIGS. 8 and 10). Toposition the engaging arms into openings 350 the user inserts theengaging arms in the openings and rotates hook clip 340 relative to thefaceplate. Retaining arm 344 keeps the hook clip from falling off of thefaceplate once the hook clip is properly attached to the faceplate.Engaging arms 342 and retaining arms 244 are configured, sized, andarranged such that a gap 358 is defined between the engaging arms andthe retaining arm. Gap 358 is large enough to accommodate a portion 360of a rail provided on the edge of the faceplate.

Hook clip 340 includes a headgear strap retaining portion 370 where theheadgear strap attaches to the hook clip. In the illustrated embodiment,the strap retaining portion includes a slot 372. The headgear strap (notshown) inserts through slip 372 for attaching the strap to hook clip340. It is to be understood that the present invention contemplates thatthe headgear strap can be attached to hook clip 340 using any technique,such as snap, hook, or other fastening mechanism.

A fourth exemplary embodiment is shown in FIGS. 15-17. In thisembodiment, patient interface 410 includes a faceplate 412 and a sealmember 414 having an oral cushion portion 422 and nares interfaceportion 424. Faceplate 412, however, is not contoured, as in theembodiment of FIGS. 8-14, but has a flat profile, like the faceplateshown in the embodiment of FIGS. 6 and 7. Seal member 414 attaches toshell 412 by means of a two-piece mounting ring 436, 438. A valve 450 asdiscussed above, is provided for selectively inflating and deflatingoral cushion portion 422 of seal member 414.

A fifth exemplary embodiment is shown in FIGS. 18-22. In thisembodiment, patient interface 510 includes a faceplate 512 and a sealmember 514 having an oral cushion portion 522 and nasal interfaceportion 524. In this embodiment, oral cushion portion 522 is a singlewall cushion having a pleat 530 defined in at least a portion of thewall. As in the previous embodiment of FIGS. 1-5, nasal interfaceportion 524 in the form of a cup-shaped protrusion integral with andextending from oral cushion portion 522. Oral cushion portion 522 isconfigured to surround the mouth of the user and side wall that includesa flap portion 580, a middle portion 582 and a base portion 584.

Flap portion 580 is configured to provide a secure seal between the oralcushion portion and the surface of the user. Base portion 584 includesan annular collar 586 of increased thickness, which may be capturedbetween shell and a retaining ring 588 having spaced capture members 590to form a seal with the faceplate. Middle portion 582 includes a pleat530 on the sides and bottom portion thereof. Pleat 530 provides anintegral corrugation, which provides a spring-type action. Pleat 530 isin the form of a groove that wraps around the sides and bottom of theoral cushion portion 522. The single wall of oral cushion portion 522with a pleat 530 of the present invention imitates the floating effectof double flap cushions, such as those disclosed in U.S. Pat. No.4,971,451, the disclosure of which is incorporated herein by reference.

A sidewall portion 594 of the oral cushion portion between annularcollar 586 and groove 592 is substantially thicker than a sidewallportion 596 between pleat 530 and flap portion 580 to provide support.Groove 592 also varies in depth, having a deeper profile at the cheekarea. A patient interface having a cushion with a pleat is disclosed inU.S. provisional patent application Ser. No. 11/312,026 (publication no.US-2006-0130844-A1) (“the '026 application”), the disclosure of which isincorporated by reference herein. One of ordinary skill in the canappreciate the seal member may take other forms, such as a cushionwithout a pleat or with multiple pleats provided at various locationsaround the seal member.

A headgear, such as those illustrated in FIGS. 27-30 may be releasablyattached to patient interface 510 by through a ball-and-socketconnection. In the illustrated embodiment, the lower corners offaceplate 512 include headgear attaching elements in the form of socketattachment elements 575 that cooperate with corresponding ball elements(not illustrated) on headgear straps. The ball-and-socket configuration,and examples of other headgear attachment configurations suitable foruse with the present invention, are disclosed in the '179 patent.

A sixth exemplary embodiment is shown in FIGS. 23 and 24. In thisembodiment, patient interface 610 includes a faceplate 612 and a sealmember 614 having an oral cushion portion 622 and nasal interfaceportion 624. Patient interface 610 includes a combination of featuresfrom previous embodiments. More specifically, seal member 614 has anoral cushion portion 622 having a pleat 630, such as that shown in FIGS.18-22, and a nasal interface portion 624, such as that shown in FIGS.8-14.

FIGS. 25 and 26 illustrate a further embodiment for a seal member 714suitable for use in the patient interface of the present invention. Inthis embodiment, seal member includes an oral cushion portion 722 and anasal interface portion 724. Oral cushion portion 722 is a single wallcushion having a pleat 730 defined in at least a portion of thesidewall. In the illustrated embodiment, the pleat extends around theentire perimeter of the oral cushion portion and terminates at each sideof the nasal interface portion. Nasal interface portion 724 is definedby a cup-shaped protrusion integral with and extending from oral cushionportion 722. Nasal interface portion includes a first opening 740 andoral cushion portion 722 includes a second opening 750. A web ofmaterial 760 separates first opening 740 from second opening 750.However, both openings 740 and 750 communicate with the interior chamberdefined by the patient interface. It can be appreciated that in thisembodiment, the nasal interface portion has a relatively low profile,meaning that it does not protrude very far from the oral cushion portionof the seal member.

FIGS. 27-30 illustrate various embodiments for the patient interfacesaccording to the principles of the present invention, shown worn by auser as part of various patient interface assemblies. It is to beunderstood that these figures illustrate only a few exemplaryconfigurations for the patient interface assembly and is not intended tobe an exhaustive illustration of all possible embodiments.

FIG. 27 illustrates an eighth embodiment of patient interface assembly900 that includes a headgear 902 and a patient interface 904. Patientinterface 904 corresponds to patient interface 110 except that the nasalinterface portion includes a pair of nasal pillows rather than acup-shaped cushion. Headgear 902 includes a pair of straps 906 and 908that extend around the back of the user's head and are joined togetherat strip portion 909. A coupling member 910 is coupled to strip portion909 such that the coupling member is selectively moveable along thestrip portion as indicated by arrow A. The position of coupling member910 on strip portion 909 can be controlled by a locking mechanism (notshown) or it can be left uncontrolled, so that the coupling member seeksthe optimum position on the strip portion for each user. A connectingstrap 912 connects coupling member 910 to a headgear clip 914.

Headgear clip 914 corresponds to the headgear clip shown in the '133application and includes a portion 916 that is selectively positionablealong rail 174. Headgear clip 914 also corresponds to the headgear clipsdisclosed in the '179 patent, and the '932 patent, and the '111application. In this manner, the connection between the headgear and thepatient interface can be adjusted, as indicated by arrow B, to suit theparticular needs/desires of the user. As can be appreciated from thisfigure, the entire body of the patient interface remains below thebridge of the nose. The lower most portion of the bridge of the nose isindicated by a reference numeral 920. The patient interface of thepresent invention does not go any further up the nose toward the eyethan this point.

FIG. 28 illustrates a ninth embodiment of a patient interface assembly940 that includes a headgear 942 and a patient interface 944. Patientinterface 944 corresponds to patient interface 310. In this embodiment,headgear straps 946 are coupled to the faceplate of the patientinterface using a hook clip 340, as discussed above with respect to theembodiment illustrated in FIGS. 8-14. Hook clip 340 can be located inany pair of openings 360 to suit the particular needs/desires of theuser. In addition to straps that wrap around the back of the head,headgear 942 includes a strap 948 that wraps over the top of the head.An optional chin strap is shown by dashed lines 950. The presentinvention also contemplates providing a cap in addition to, or in placeof the headgear straps. An example of such a cap is disclosed in U.S.Pat. No. 6,805,117.

FIG. 29 illustrates a tenth embodiment of a patient interface assembly960 that includes a headgear 962 and a patient interface 964. Patientinterface 964 corresponds to patient interface 310. In this embodiment,headgear 962 includes two attachment points with the faceplate ofpatient interface 964. In other words, two hook clips 340 are disposedon one side of the faceplate to connect a first strap 966 and a secondstrap 968 to the faceplate. An optional chin strap is shown by dashedlines 970, and an optional over the head strap is shown by dashed lines972.

FIG. 30 illustrates an eleventh embodiment of a patient interfaceassembly 980 that includes a headgear 982 and a patient interface 984.In this embodiment, patient interface 984 includes a three-pointattachment technique whereby three headgear straps 986, 988, and 990 arecoupled to the patient interface. In this embodiment, slots 992, 994,and 996 are provided in the faceplate for receiving straps 986, 988, and990, respectively. The lower strap 990 is connected to a chin strap 998.

This embodiment also illustrates cup-like a nasal interface portion thatcorresponds, for example, to nasal interface portion 124 of FIGS. 1-5.It can be appreciated that when the patient interface is worn by theuser, the nasal interface portion of the seal member extends over thetip of the nose, but does not extend so far up the nose toward the eyesso as to overlie any portion of the bridge of the nose, the lowermostportion of which is indicated by reference numeral 920. The presentinvention contemplates that the nasal interface portion of the sealmember can extend up the nose toward the eyes farther than shown in FIG.30, so long as it does not overly the bridge of the nose.

A twelfth embodiment of a patient interface 1000 is illustrated in FIGS.32-34. Patient interface 1000 includes a faceplate 1002 and a sealmember 1004 attached to the faceplate. Faceplate 1002 is a rigid orsemi-rigid structure having a generally curved configuration andincludes an opening or port 1006 for connecting to a patient circuit ora patient interface coupling. It should be noted that headgearattachment elements are not shown on faceplate 1002 to simplify theillustration. It is to be understood that the present inventioncontemplates using any suitable technique to attach the headgear to thefaceplate.

As in the previous embodiments, seal member 1004 includes an oralcushion portion 1010 and a nasal interface portion 1012. Seal member1004 is similar to the seal member shown in FIGS. 26 and 26 in that aweb of material 1014 is provided between an opening 1016 in the oralcushion portion and an opening 1018 in the nasal interface portion. Inthis embodiment, nasal interface portion 1012 protrudes some distancefrom a surface of a sidewall of the oral cushion portion.

In addition, a pleat 1020 is provided in the material at the frontportion of the nasal interface portion, i.e., the portion that is closerto the tip of the nose when the interface is worn by the user. Pleat1020, in addition to enhancing the flexibility of the walls of the natalinterface portion, allows the patient contacting surface of the nasalinterface portion to move in a direction indicated by arrow 1022, sothat nasal interface portion properly seats itself on the user. Thedirection indicated by arrow 1022 corresponds, in general, to a verticaldirection that is generally parallel to the face of the user. On theother hand, the patient contacting portion of oral cushion portion 1004moves in a direction generally indicated by arrow 1024, so that the oralcushion portion compresses to properly seat itself on the user. Thedirection indicated by arrow 1024 is generally perpendicular todirection indicated by arrow 1022. This ability for oral cushion portion1010 and nasal interface portion 1012 to be compressed or move indifferent directions, while still being defined by a unitary piece ofmaterial, provides the ability of patient interface 1000 to fit a widevariety of differently sized users.

In this embodiment, as best illustrated in FIG. 34, which is across-sectional view of patient interface 1000, seal member 1004 is acup-shaped member, having a wall 1026 that is distal from patientcontacting portion 1028 of the oral cushion portion. Wall 1026 isgenerally adjacent to faceplate 1002 when the faceplate is assembledwith the seal member. A sidewall 1029 extends from wall 1026 to patientcontacting portion 1028. An opening 1030 is defined in wall 1026 toreceive a coupling portion 1032 of faceplate 1002. In addition, a groove1034 is defined in the faceplate and a protrusion 1036 is provided inthe seal member such that the groove and the protrusion cooperate withone another to maintain the seal member and the faceplate in anassembled configuration and/or properly oriented relative to oneanother. Thus, the seal member alone, i.e., without the faceplate,defines a chamber 1038 that serves as a nose receiving cavity. It is tobe understood that that the present invention contemplates othertechniques and configurations for coupling faceplate 1002 to seal member1004 in addition to or in place of that shown in the figures.

The present invention also contemplate eliminating the faceplateentirely. In which case, the headgear attachment mechanism is provideddirectly on the seal member. In addition, the patient circuit couplingis also provided directly on the seal member. As in the previousembodiment, any suitable technique can be used to couple the headgearstraps and the patient circuit directly to the seal member. Of course,portions of the seal member can be reinforced, thickened, or otherwisestiffened to support the headgear attachments and the patient circuitcoupling.

FIGS. 35 and 36 illustrate a thirteenth embodiment of the patientinterface 1050 according to the principles of present invention. Patientinterface 1050 includes a faceplate 1052 and a seal member 1054 attachedto the faceplate. Seal member 1054 includes an oral cushion portion 1060and a nasal interface portion 1062. In this embodiment, the seal memberis generally similar to that of FIGS. 32-34, except that a groove orpleat 1064 is defined around a perimeter of oral cushion portion 1060.Groove 1064 enhances the flexibility of the seal member is a directionnormal to the surface of the patient. In addition, a relatively largeflap 1066 is provided in the patient contacting portion of the sealmember, and, in particular, at lower portion of the oral cushion portionthat is below the user's mouth when the patient interface is worn by theuser. Of course, the large flap can be located at other locations alongthe perimeter of the seal or at multiple locations. This flap helpsprovided a leak resistance seal against the user. The patient contactportion of the seal member also includes angled portions 1068 to providethe desired sealing characteristics against the surface of the user.

FIGS. 37 and 38 illustrate fourteenth embodiment for a patient interface1100 having a faceplate 1102 and a seal member 1104 attached to thefaceplate. Seal member 1104 includes an oral cushion portion 1106 and anasal interface portion 1108. In this embodiment, nasal interfaceportion 1108 includes a pair of nasal pillows or prongs 1110, each ofwhich extends from the oral cushion portion of the seal member. Thenasal prongs in this embodiment include a stem portion 1112 and aninterface portion 1114 disposed at the end of the stem portion. Anopening 1116 is defined in the interface portion of the nasal prong. Thestem portion is sufficiently flexible so that the nasal prong can moveto fit a variety of differently sized patients. In this embodiment, agroove or pleat 1118 is provided around the perimeter of the oralcushion portion. Groove 1118 also extends around the nasal interfaceportion of the seal member, as indicated by reference numeral 1120.

FIGS. 39-41 illustrate a fifteenth embodiment of a patient interface1150 having a faceplate 1152 and a seal member 1154 attached to thefaceplate. Seal member 1154 includes an oral cushion portion 1156 and anasal interface portion 1158. The nasal interface portion of the sealmember is structurally similar to that shown in FIGS. 1-7 18-22 andincludes a flexible peripheral wall 1160 extending from the oral cushionportion of the seal member. Nasal interface portion 1158 also includes arigid or semi-rigid band 1162 that is attached to wall 1160. Inexemplary embodiment, band 1162 is capable of being bent (inward oroutward) and is capable of retaining the new shape upon being bent, sothat the nasal interface portion can be configured to particularanatomical attributes of the user.

The present invention contemplates attaching band 1162 to wall 1160using any suitable technique, including permanently or removeablymounting the band on the wall. A permanent attachment can be achieved byadhering the band to the wall. A removeable attachment is shown in FIGS.39-41. A removeable attachment allows different bands, for example bandshaving different sizes, stiffnesses, or degrees of flexibility, to beused with the nasal interface portion. In the illustrated embodiment,band 1162 includes notches 1164 that attach to protrusions 1166 providedon wall 1160.

FIG. 42 illustrates a sixteenth embodiment of a seal member 1200suitable for use in the patient interface of the present invention. Sealmember 1200 includes an oral cushion portion 1202 and a nasal interfaceportion 1204. The oral cushion portion of the seal member is agas-filled bladder. The nasal interface portion is defined by a singleopening 1206 that extends through the gas-filled bladder. An optionalflap 1208 is provided around at least a portion of opening 1206 to helpseal the nasal interface portion around the nasal passages of the user.It is to be understood that the present invention contemplates that thebladder can be filled, in whole or in part, with other materials, suchas a gel or foam.

FIG. 43 illustrates a seventeenth embodiment of a seal member 1250according the principles of the present invention. Seal member 1200includes an oral cushion portion 1252 and a nasal interface portion1254. The oral cushion portion of the seal member, as in the embodimentof FIG. 42, is a gas-filled bladder. In this embodiment, however, thenasal interface portion is defined by a pair of nasal prongs 1256, eachof which includes an opening 1258 that extends through the gas-filledbladder. Each nasal prong includes a protrusion or bulbous portion 1260.In an exemplary embodiment, the bulbous portion is defined by thematerial forming the gas-filled bladder.

FIGS. 44 and 45 illustrate an eighteenth embodiment of a patientinterface 1300 according to the principles of the present inventionshown worn by a user. Patient interface 1300 includes a seal member 1304having an oral cushion portion 1306 and a nasal interface portion 1308.A coupling 1310 is rotatably attached to one side of seal member 1310 toconnect conduit 116 to the patient interface. Coupling 1310 can bepermanently coupled to the seal member or selectively coupled, asindicated by arrow 1309 in FIG. 45. The present invention alsocontemplates that the conduit can be attached to the seal member atother locations or at more than one location. An exhaust vent assembly1312 is provided on coupling 1310. Conduit 116 can be fixed or rotatablyattached to coupling 116.

Nasal interface portion 1308, in this exemplary embodiment, is a pair ofpillows/prongs, each of which extends from the oral cushion portion ofthe seal member. Similar prongs are illustrated in FIGS. 37 and 38. Ofcourse, any of the nasal interface portions can be used in seal member1310. Oral cushion portion 1306 extends around the mouth and down towardthe user's chin. In an exemplary embodiment, the oral cushion portion isformed from a flexible or semi-rigid material or combination ofmaterials.

A headgear assembly, generally indicated at 1320, couples patientinterface 1300 to the user. In this exemplary embodiment, the headgearassembly includes a pair of straps 1322, 1324 that extend from each sideof patient interface 1300. Two coupling members 1326 and 1328 arecoupled to straps 1322 and 1324 and extend around the head of the user.The length of straps 1322, 1324 and/or coupling members 1326 can beadjusted to fit the headgear on a variety of differently sized heads.The present invention further contemplates providing stiffening members1330 and 1332 coupled to straps 1322 and 1324. Stiffening members 1330and 1332 can have any suitable configurations, can be formed frommultiple components, can be shaped or curved to match or conform to thesurface of the user, can be made from any suitable material orcombination of materials, and may be disposed over or provided withinthe material forming the straps. In addition, suitable stiffening membercan also be coupled to coupling members 1326 and 1328.

Headgear assembly 1330 also includes various components for securinginterface 1300 to the chin or mandible of the user. In this illustratedexemplary embodiment, a pair of side straps 1340, 1342 and a chin strap1344 are connected to oral cushion portion 1306 of seal member 1304.Chin strap 1344 extends down generally from the center of the oralcushion portion along the midline of the user over the chin and underthe mandible. Side straps 1340, 1342 extend from straps 1322, 1324 alongthe sides of the fact and join the chin strap under the mandible. Thepresent invention contemplates that straps 1340, 1342, and 1344 areformed from a flexible, stretchable material. Of course, othermaterials, including rigid or semi-rigid structures can be provided.

FIG. 46 is a side view of a nineteenth embodiment of a patient interface1350 having a faceplate 1352 and a seal member 1354 attached to thefaceplate. Seal member 1354 includes an oral cushion portion 1356 and anasal interface portion 1358. In this embodiment, seal member 1354includes at least one groove or pleat 1360 defined proximate to theportion of the seal member that contacts the user. An example of agroove or multiple grooves suitable for use in the present invention,and, in particular, the present embodiment, is disclosed in the '026application. The present invention also contemplates forming a portionof seal member 1354 with a gel material to maximize patient comfort. Aportion of the seal member that contacts the user is formed form a soft,compliant material, such as silicon.

FIG. 47 illustrates a twentieth embodiment of a patient interface 1370having a faceplate 1374 and a seal member 1372 attached to thefaceplate. Seal member 1372 includes an oral cushion portion 1376 and anasal interface portion 1378. In this embodiment, the seal memberincludes multiple grooves or pleats 1380, 1382 An example of a groove ormultiple grooves suitable for use in the present invention, and, inparticular, the present embodiment, is disclosed in the '026application. The present invention also contemplates forming a portion1386 of seal member 1374 with a gel material to maximize patientcomfort. In this embodiment, unlike that of FIG. 46, gel portion 1386 issmaller and is provided as a layer or components of the larger sealmember. The portion 1390 of the seal member that contacts the user isformed form a soft, compliant material, such as silicon. A base portion1392 of the cushion contacts faceplate 1374. This portion can be formedfrom any suitable substance that will support both gel layer 1386 andthe distal flap portion is also formed from FIGS. 48-50 illustrate atwenty-first embodiment of a patient interface 1400 having a faceplate1402 and a seal member 1404 attached to the faceplate. Seal member 1404includes an oral cushion portion 1406 and a nasal interface portion1408. Faceplate 1402 and seal member 1404 are joined or coupled togethervia a mounting ring 1410. Of course, other techniques for selectively orpermanently joining the faceplate and seal member, such as providing atongue and groove in these components in addition to or in place of themounting ring, are contemplated by the present invention.

In the presently illustrated embodiment, a headgear coupling assembly1420 is provided on each side of the faceplate. More specifically,headgear coupling assembly 1420 includes sockets 1422 that correspond tothe socket portion a portion of a ball-and-socket headgear attachmenttechnique, as discussed above and as disclosed, for example, in the '179patent. Multiple sockets are provided so that the user can select whichsockets to use to connect to the ball portion of the headgear clip. Ofcourse, more or less sockets can be provided. In addition, sockets 1422can be provided at different locations on the faceplate or have otherconfigurations. Indeed, the present invention contemplates using anyheadgear attachment element to couple the headgear strap to the patientinterface, and, in particular, the faceplate.

FIGS. 51-53 illustrate a twenty-second embodiment of a patient interface1500 having a faceplate 1502 and a seal member 1504 attached to thefaceplate. Seal member 1504 includes an oral cushion portion 1506 and anasal interface portion 1508. Faceplate 1502 and seal member 1504 arejoined or coupled together via a mounting ring 1510. Of course, othertechniques for selectively or permanently joining the faceplate and sealmember, such as providing a tongue and groove in these components inaddition to or in place of the mounting ring, are contemplated by thepresent invention.

This embodiment illustrates an example of another variation for aheadgear coupling assembly 1520 associated with faceplate 1502. Headgearcoupling assembly 1520 is generally similar to that shown in use withthe patient interfaces illustrated in FIGS. 8-11. Each headgear couplingassembly includes a plurality of openings 1522 that are used to attachheadgear clips to the faceplate. As noted above, an example of aheadgear clip that can be attached to headgear coupling assembly 1520are hook clips 340, as shown for example, in FIGS. 13-14. Of course, theconfiguration for headgear coupling assemblies 1520 and openings 1522can be varied so long as the function of providing an attachmentstructure for securing a headgear to the patient interface isaccomplished.

The present invention contemplates that features known in the art foruse with cushions, faceplates, and masks in general, can be used withthe patient interface embodiments of the present invention. For example,it is known to provide reinforcing structures in a seal member tosupport all or portions of the seal member. Examples of such reinforcingportions are ribs coupled to the seal member and rigid or semi-rigidmaterials defined in the seal member or disposed adjacent to the sealmember. It is also known to provide multiple flaps generally at thedistal portion of the seal member, which is the portion that contactsthe user. See, e.g., U.S. Pat. No. 4,971,451. This multiple flapconfiguration can be used with the seal member of the present invention.

The present invention further contemplates that patient interfacecoupling 118 is any device capable of attaching the patient interface toa patient circuit. It can be a simple conduit or it can includeadditional features, such as exhalation ports, entrainment valve, quickrelease mechanisms, or any combination thereof. Examples of patientinterface couplings suitable for use in the present invention aredisclosed in U.S. Pat. Nos. 6,851,425; 5,647,355; and 5,438,981 thecontents of each of which are incorporated herein by reference. U.S.patent application Ser. No. 11/312,027 also teaches patient interfacecouplings suitable for use in the present invention.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

1. A patient interface comprising: a seal member adapted to contact aface of a user to provide a sealed interface with such a user, whereinthe seal member comprises: (1) an oral cushion portion adapted toprovide a sealed interface with such a user, wherein a sealing of theoral cushion portion at least partially surrounds a mouth of such auser, and (2) a nasal interface portion integral with the oral cushionportion, wherein the nasal interface portion is adapted to contact atleast a portion of a nose of such as user below a bridge of the nose toprovide a sealed interface with a surface of such a user proximate tothe nares of such a user.
 2. The patient interface of claim 1, whereinthe nasal interface portion comprises a protrusion that extends from theoral cushion portion, and wherein the protrusion is sized and configuredthat the protrusion is bounded at its upper extremity by a lower end ofa nose of such a user.
 3. The patient interface of claim 1, wherein thenasal interface portion comprises is a nasal cup or a pair of nasalpillows.
 4. The patient interface of claim 1, wherein the nasalinterface portion comprises is a pair of nasal pillows, and wherein thenasal pillows both have a generally concave exterior shape.
 5. Thepatient interface of claim 1, wherein the oral cushion portion includesa first end portion, a second end portion adapted to contact a surfaceof a user, and a wall extending between the first end portion and thesecond end portion.
 6. The patient interface of claim 5, wherein a pleatis defined in the wall.
 7. The patient interface of claim 5, wherein achamber is defined by the oral cushion portion, and wherein the secondend portion includes a distal edge portion that extends generally towardthe chamber.
 8. The patient interface of claim 1, wherein the oralcushion portion comprises a bladder having an interior.
 9. The patientinterface of claim 8, wherein the interior of the bladder is gas-filledor gel-filled.
 10. The patient interface of claim 8, wherein theinterior of the bladder is gas-filled and further comprising a valve forcontrolling inflation of the gas-filled interior.
 11. The patientinterface of claim 1, wherein a first opening is defined in the oralcushion portion to provide a seal around such a user's mouth and asecond opening is defined in the nasal interface portion to provide aseal around at least one of such a user's nares.
 12. The patientinterface of claim 1, wherein the oral cushion portion is generally ovalshaped.
 13. The patient interface of claim 1, further comprising areinforcing member associated with the oral cushion portion, the nasalinterface portion, or both to provide structural support for anassociated portion of the seal member.
 14. The patient interface ofclaim 1, further comprising a faceplate, wherein the seal member iscoupled to the faceplate.
 15. The patient interface of claim 14, furthercomprising means for attaching the seal member to the faceplate.
 16. Thepatient interface of claim 1, further comprising a headgear coupled tothe faceplate.
 17. The patient interface of claim 15, further comprisingmeans for attaching the headgear to the faceplate.
 18. The patientinterface of claim 1, wherein the faceplate includes a headgearattachment element.
 19. The patient interface of claim 1, furthercomprising a patient circuit connector rotateably attached to the shell.